Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Mindfulness Relaxation, Mindfulness Relaxation, Mindfulness Relaxation.
- Who it may be relevant to
- Registry conditions: Chronic Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease
Overview
This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.
Detailed description
PRIMARY OBJECTIVE:
I. Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner/patient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).
SECONDARY OBJECTIVES:
I. Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.
II. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.
III. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.
EXPLORATORY OBJECTIVE:
I. Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.
OUTLINE:
Patients complete group sessions once weekly (QW), on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.
Interventions
- Procedure Biospecimen Collection
Undergo blood sample collection - Behavioral Mindfulness Relaxation
Complete group mindfulness sessions - Behavioral Mindfulness Relaxation
Complete individual mindfulness session - Behavioral Mindfulness Relaxation
Complete daily self meditation - Other Survey Administration
Ancillary studies
Primary outcome measures
- Compliance (feasibility) [Time frame: Up to 8 weeks]
Secondary outcome measures (4)
- Reason for not starting study activities after signing consent [Time frame: Up to 8 weeks]
- Feasibility of daily meditation in patients with a diagnosis of cGVHD [Time frame: Up to 8 weeks]
- Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS [Time frame: From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks]
- Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria [Time frame: From baseline to completion of MBI program, up to 8 weeks]
Eligibility criteria
Inclusion criteria
- Documented informed consent of the participant and/or legally authorized representative
- Willingness to participate in the study
- Willingness to attend in-person or virtual group sessions
- Ability to read and understand English (required for protocol therapy and planned survey)
- Age: ≥ 18 years
- Confirmed diagnosis of moderate/severe chronic graft-versus-host disease by National Institute of Health (NIH) criteria
- Karnofsky performance status ≥ 80
Exclusion criteria
- Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
- An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
- Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
- Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07733141 · 25870 · NCI-2026-04201 · 25870 · P30CA033572